NCT05874414

Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma

Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	GNS561 + Trametinib	GNS561: 50mg, 100mg, 150mg, 200mg and trametinib: 1mg, 1.5mg and 2mg

Timeline

• Start date: 2023-08-21
• Primary completion: 2026-05-01
• Completion: 2026-10-01
• First posted: 2023-05-24
• Last updated: 2026-01-22

Locations

11 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study